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An Assessment of the Accutane (Isotretinoin) Pregnancy Prevention Program

An Assessment of the Accutane (Isotretinoin) Pregnancy Prevention Program. Allen A. Mitchell, M.D. Carla Van Bennekom, R.N., M.P.H. Carol Louik, Sc.D. Slone Epidemiology Unit Boston University School of Public Health. Pregnancy Prevention Program (PPP):. Introduced in fall, 1988

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An Assessment of the Accutane (Isotretinoin) Pregnancy Prevention Program

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  1. An Assessment of theAccutane (Isotretinoin)Pregnancy Prevention Program Allen A. Mitchell, M.D. Carla Van Bennekom, R.N., M.P.H. Carol Louik, Sc.D. Slone Epidemiology Unit Boston University School of Public Health

  2. Pregnancy Prevention Program (PPP): • Introduced in fall, 1988 • Multi-component program • Aimed at female patients and their physicians • Unprecedented and novel approach

  3. Does the PPP work?

  4. Survey of Accutane Use in Women Sponsored by: Hoffmann-La Roche, Inc. SEU Responsible for: - Design/Protocol - Data Collection - Data Processing - Data Analysis Guidance provided by: Independent Advisory Committee

  5. Paul D. Stolley, M.D., Chair* University of Maryland School of Medicine Baltimore, MD Edward L. Decker, Pharm.D. New England Medical Center Boston, MA Karen McKoy, M.D. Lahey Clinic Burlington, MA Observers: Charlotte Catz, M.D., NICHD John Melski, M.D. Marshfield Clinic Marshfield, WI Peter Pochi, M.D. Boston University School of Medicine Boston, MA Robert S. Stern, M.D. Harvard Medical School Boston, MA José F. Corderó, M.D., CDC Slone Epidemiology UnitAccutane Survey Advisory Committee1988 - 2000 *Dr. Stolley resigned as Committee Chair on July 19, 2000 because he has joined the FDA as a Senior Consultant.

  6. Objectives To assess compliance with the Pregnancy Prevention Program • Awareness of the teratogenic risk • Patient and physician behaviors • Pregnancy rate • Pregnancy outcome • Risk factors for pregnancy

  7. Limitations • No pilot testing • No pre/post comparison • What is “success”? • Survey itself is an intervention • Voluntary enrollment/? representativeness

  8. Accutane Survey Design

  9. Accutane SurveyTIME PERIOD OF INTEREST(Duration of Follow-up)

  10. To Encourage Enrollment • Multiple/different opportunities • Keep it simple • Provide payment

  11. Enrollment Opportunities 1) Physician-generated • All prescriptions originate with physician • Logistically feasible • Strong incentive

  12. Enrollment Opportunities 2) Toll-free telephone call • Simple • Quick • Familiar

  13. Enrollment Opportunities 3) Package-generated • Unique • Direct to patient • Bypasses physician • May preferentially target women who • were not encouraged by their physician • may be relatively noncompliant • are attracted by payment

  14. Follow-Up Approaches Frequent: During and After Treatment (DAT) Advantage - Avoid recall bias Disadvantage - ? Affect outcome beyond PPP

  15. Follow-Up Approaches Infrequent: After Treatment only (AT) Advantage - Avoids intervention beyond PPP Disadvantage - Potential recall bias

  16. Information Obtained at Follow-Up

  17. Accutane Survey Results

  18. Accutane SurveyEnrollments: 1989-1999 Cumulative enrollments through 6/30/00: >494,000

  19. Method of Enrollment

  20. Follow-Up Rates During and After Treatment (“DAT”) Number to date (6/00): 61,659 1/89 - 12/94 (telephone) 32,301 Completed Follow-Up: Tx start 98% Tx middle 98% 6 mos.`p Tx 93%

  21. Follow-Up Rates During and After Treatment (“DAT”) 1/95 - 6/00 (mail) 29,358 Completed Follow-Up: Tx start 98% Tx middle 98% 6 mos.`p Tx 97%

  22. Follow-Up Rates After Treatment (“AT”) Number to date (6/00): 433,256 Completed Follow-Up: 6 mos.`p Tx 80-86%

  23. Accutane Survey Results: Demographics

  24. Age1/89 – 6/00(n=494,915) Mean (years) 25.6 Median (years) 24

  25. Age of Enrollees by Enrollment Year

  26. Highest Level of Education

  27. Type of Prescriber

  28. Past Treatment for Acne

  29. Pregnancy Risk Categories(at DAT 1)1/95 – 6/00(n=28,016) 3% Hysterectomy/postmenopausal 57% Not sexually active 40% Sexually active

  30. Pregnancy Risk Categories(at DAT 1)1/95 – 6/00(n=28,016) 57% Not sexually active: Using birth control 44% Not using birth control 56% 100% 40% Sexually active: Using birth control 98% Not using birth control 2% 100%

  31. Accutane Survey Results: Women’s Knowledge

  32. Receipt of PPP Information1/95 – 6/00(n=28,386) Patient brochure 92% True/false test 42% Birth Control brochure 53%

  33. Knowledge of Accutane Risk1/95 – 6/00(n=28,386) May cause miscarriage 43% May cause birth defects 99%

  34. Accutane Survey Results: Compliance

  35. Compliance with PPP – I1/95 – 6/00(n=28,386) Told to avoid pregnancy 99% Signed consent form 77% Postpone Accutane until pregnancy test 67% Postpone Accutane until next menstrual period 57%

  36. Compliance with Selected Measures of the PPP n=5,108 n=5,157 n=5,206 n=5,047 n=5,283 n=2,585

  37. Compliance with PPP – IIPregnancy Testing1/95 – 6/00(n=27,073) Serum 56% Urine 9% Both serum and urine 8% Any 76% None 24%

  38. Pregnancy Testing Before Starting Accutane by Enrollment Year n=5,108 n=5,157 n=5,206 n=5,047 n=5,283 n=2,585

  39. Knowledge and Compliance at Onset of Therapy1989 -1990(n=9,365)

  40. Original Medication Package

  41. Revised Medication Package

  42. Knowledge and Compliance at Onset of Therapy

  43. Compliance with PPP - III Contraceptive Status, By Age

  44. Contraceptive StatusNoncontraceptors by Age Group

  45. Contraceptive StatusSurgical Sterility by Age Group

  46. Contraceptive StatusNonsurgical Contraception by Age Group

  47. Contraceptive StatusNonsurgical Contraception by Enrollment Year

  48. Among Nonsurgical Contraceptors, % Reporting Oral Contraceptive Use by Enrollment Year

  49. Among Contraceptors% Reporting Use of 2+ Methods by Age Group

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